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Wellbutrin XL Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Wellbutrin XL (bupropion hydrochloride extended-release) is an antidepressant used to treat major depressive disorder and seasonal affective disorder. At least one brand of bupropion (Zyban) is used to help people stop smoking by reducing cravings and other withdrawal effects. Wellbutrin XL is available in generic form. Common side effects of Wellbutrin XL include dry mouth, sore throat, nausea, vomiting, stomach/abdominal pain, flushing, headache, changes in appetite, weight loss or gain, constipation, trouble sleeping, increased sweating, increased urination, itching or skin rash, strange taste in mouth, joint aches, muscle pain, dizziness, ringing in your ears, loss of interest in sex, or blurred vision.
The initial dose of Wellbutrin XL is 150 mg/day as a single dose. The target dose is 300-mg/day. Wellbutrin XL may interact with cancer medicines, heart rhythm medications, heart or blood pressure medications, other antidepressants, medicine to treat psychiatric disorders, antihistamines, asthma medications or bronchodilators, birth control pills or hormone replacement estrogens, bladder or urinary medications, antibiotics, diet pills, stimulants, ADHD medication, insulin or oral diabetes medications, medication for nausea/vomiting/motion sickness, medications to treat/prevent malaria, medicines to treat Parkinson's disease/restless leg syndrome/pituitary gland tumor, medicines used to prevent organ transplant rejection, narcotics, sedatives, steroids, theophylline, or ulcer or irritable bowel medications. Tell your doctor all medications you use. Wellbutrin XL should be used only when prescribed during pregnancy. Infrequently, newborns whose mothers have used certain antidepressants during the last 3 months of pregnancy may develop symptoms including persistent feeding or breathing difficulties, jitteriness, seizures or constant crying. Report symptoms to the doctor. Do not stop taking this medication unless your doctor directs you to do so. This drug passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.
Our Wellbutrin XL (bupropion hydrochloride extended-release) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Wellbutrin XL in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.
Call your doctor at once if you have:
- seizure (convulsions);
- fast heartbeats;
- fever, swollen glands, rash or itching, joint pain, or general ill feeling;
- confusion, trouble concentrating, hallucinations, unusual thoughts or behavior; or
- severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.
Less serious side effects may include:
- dry mouth, nausea, stomach pain;
- headache, dizziness, ringing in your ears;
- loss of interest in sex;
- sore throat, muscle pain;
- mild itching or skin rash, increased sweating, increased urination; or
- changes in appetite, weight loss or gain.
Read the entire detailed patient monograph for Wellbutrin XL (Bupropion Hydrochloride Extended-Release)
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Wellbutrin XL Overview - Patient Information: Side Effects
Dry mouth, sore throat, dizziness, nausea, vomiting, ringing in the ears, headache, decreased appetite, weight loss, constipation, trouble sleeping, increased sweating, or shaking (tremor) may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
An empty tablet shell may appear in your stool. This effect is harmless because your body has already absorbed the medication.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.
Tell your doctor right away if you have any serious side effects, including: fast/pounding/irregular heartbeat, mental/mood changes (such as anxiety, agitation, confusion, unusual behavior/thinking, memory loss), unusual weight loss or gain.
Stop taking bupropion and get medical help right away if you have any very serious side effects, including: seizure, eye pain/swelling/redness, vision changes (such as seeing rainbows around lights at night, blurred vision).
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), painful sores in the mouth/around the eyes, severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Wellbutrin XL (Bupropion Hydrochloride Extended-Release)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Wellbutrin XL FDA Prescribing Information: Side Effects
The following adverse reactions are discussed in greater detail in other sections of the labeling:
- Suicidal thoughts and behaviors in children, adolescents, and young adults [see WARNINGS AND PRECAUTIONS]
- Neuropsychiatric symptoms and suicide risk in smoking cessation treatment [see WARNINGS AND PRECAUTIONS]
- Seizure [see WARNINGS AND PRECAUTIONS]
- Hypertension [see WARNINGS AND PRECAUTIONS]
- Activation of mania or hypomania [see WARNINGS AND PRECAUTIONS]
- Psychosis and other neuropsychiatric events [see WARNINGS AND PRECAUTIONS]
- Angle Closure Glaucoma [see WARNINGS AND PRECAUTIONS]
- Hypersensitivity reactions [see WARNINGS AND PRECAUTIONS]
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
Commonly Observed Adverse Reactions in Controlled Clinical Trials of Sustained-Release Bupropion Hydrochloride
Adverse reactions that occurred in at least 5% of patients treated with bupropion HCl sustained-release (300 mg and 400 mg per day) and at a rate at least twice the placebo rate are listed below.
400 mg/day of bupropion HCl sustained-release: abdominal pain, agitation, anxiety, dizziness, dry mouth, insomnia, myalgia, nausea, palpitation, pharyngitis, sweating, tinnitus, and urinary frequency.
WELLBUTRIN XL has been demonstrated to have similar bioavailability both to the immediate-release and sustained-release formulations of bupropion. The information included under this subsection and under the subsection 6.2 is based primarily on data from controlled clinical trials with the sustained-release and extended release formulations of bupropion hydrochloride.
Major Depressive Disorder
Adverse Reactions Leading to Discontinuation of Treatment with Bupropion HCl Immediate-Release, Bupropion HCl Sustained-Release, and Bupropion HCl Extended-Release in Major Depressive Disorder Trials
In placebo-controlled clinical trials with bupropion HCl sustained-release, 4%, 9%, and 11% of the placebo, 300 mg/day and 400 mg/day groups, respectively, discontinued treatment because of adverse reactions. The specific adverse reactions leading to discontinuation in at least 1% of the 300 mg/day or 400 mg/day groups and at a rate at least twice the placebo rate are listed in Table 2.
Table 2: Treatment Discontinuation Due to Adverse
Reactions in Placebo-Controlled Trials in MDD
|Adverse Reaction Term||Placebo
|Bupropion HCl Sustained-Release 300 mg/day
|Bupropion HCl Sustained-Release 400 mg/day
In clinical trials with bupropion HCl immediate-release, 10% of patients and volunteers discontinued due to an adverse reaction. Reactions resulting in discontinuation, (in addition to those listed above for the sustained-release formulation), included vomiting, seizures, and sleep disturbances.
Adverse Reactions Occurring at an Incidence of > 1% in Patients Treated with Bupropion HCl Immediate-Release or Bupropion HCl Sustained-Release in MDD
Table 3 summarizes the adverse reactions that occurred in placebo-controlled trials in patients treated with bupropion HCl sustained-release 300 mg/day and 400 mg/day. These include reactions that occurred in either the 300 mg or 400 mg group at an incidence of 1% or more and were more frequent than in the placebo group are included.
Table 3: Adverse Reactions in Placebo-Controlled
Trials in Patients with MDD
|Body System/ Adverse Reaction||Placebo
|Bupropion HCl Sustained-Release 300 mg/day
|Bupropion HCl Sustained-Release 400 mg/day
|Central nervous system stimulation||1%||2%||1%|
|Blurred vision of diplopia||2%||3%||2%|
|Urinary tract infection||†||1%||0%|
|* Incidence based on the number
of female patients.
† Hyphen denotes adverse reactions occurring in greater than 0 but less than 0.5% of patients
The following additional adverse reactions occurred in controlled trials of bupropion HCl immediate-release (300 to 600 mg per day) at an incidence of at least 1% more frequently than in the placebo group were: cardiac arrhythmia (5% vs. 4%), hypertension (4% vs. 2%), hypotension (3% vs. 2%), menstrual complaints (5% vs. 1%), akathisia (2% vs. 1%), impaired sleep quality (4% vs. 2%), sensory disturbance (4% vs. 3%), confusion (8% vs. 5%), decreased libido (3% vs. 2%), hostility (6% vs. 4%), auditory disturbance (5% vs. 3%), and gustatory disturbance (3% vs. 1%).
Seasonal Affective Disorder
In placebo-controlled clinical trials in SAD, 9% of patients treated with WELLBUTRIN XL and 5% of patients treated with placebo discontinued treatment because of adverse reactions. The adverse reactions leading to discontinuation in at least 1% of patients treated with bupropion and at a rate numerically greater than the placebo rate were insomnia (2% vs. < 1%) and headache (1% vs. < 1%).
Table 4 summarizes the adverse reactions that occurred in patients treated with WELLBUTRIN XL for up to approximately 6 months in 3 placebo-controlled trials. These include reactions that occurred at an incidence of 2% or more and were more frequent than in the placebo group.
Table 4: Adverse Reactions in Placebo-Controlled
Trials in Patients with SAD
|System Organ Class/ Preferred Term||Placebo
|Bupropion HCl Extended-Release
|Abdominal pain||< 1%||2%|
|Nervous System Disorders|
|Infections and Infestations|
|Upper respiratory tract infection||8%||9%|
|Musculoskeletal and Connective Tissue Disorders|
|Pain in extremity||2%||3%|
|Respiratory, Thoracic, and Mediastinal Disorders|
|General Disorders and Administration Site Conditions|
|Skin and Subcutaneous Tissue Disorders|
|Metabolism and Nutrition Disorders|
|Reproductive System and Breast Disorders|
|Ear and Labyrinth Disorders|
Changes in Body Weight
Table 5 presents the incidence of body weight changes ( ≥ 5 lbs) in the short-term MDD trials using bupropion HCl sustained-release. There was a dose-related decrease in body weight.
Table 5: Incidence of Weight
Gain or Weight Loss ( ≥ 5 lbs.) in MDD Trials Using Bupropion HCl
|Weight Change||Bupropion HCl Sustained-Release 300 mg/day
|Bupropion HCl Sustained-Release 400 mg/day
|Gained > 5 lbs||3%||2%||4%|
|Lost > 5 lbs||14%||19%||6%|
Table 6 presents the incidence of body weight changes ( ≥ 5 lbs) in the 3 SAD trials using bupropion HCl extended-release. A higher proportion of subjects in the bupropion group (23%) had a weight loss ≥ 5 lbs., compared to the placebo group (11%). These were relatively long-term trials (up to 6 months).
Table 6: Incidence of Weight Gain or Weight Loss
( ≥ 5 lbs) in SAD Trials Using Bupropion HCl Extended-Release
|Weight Change||Bupropion HCl Extended-Release 150 to 300 mg/day
|Gained > 5 lbs||11%||21%|
|Lost > 5 lbs||23%||11%|
The following adverse reactions have been identified during post-approval use of WELLBUTRIN XL. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Abnormal liver function, bruxism, gastric reflux, gingivitis, glossitis, increased salivation, jaundice, mouth ulcers, stomatitis, thirst, edema of tongue, colitis, esophagitis, gastrointestinal hemorrhage, gum hemorrhage, hepatitis, intestinal perforation, liver damage, pancreatitis, and stomach ulcer.
Hemic and Lymphatic
Ecchymosis, anemia, leukocytosis, leukopenia, lymphadenopathy, pancytopenia, and thrombocytopenia. Altered PT and/or INR, associated with hemorrhagic or thrombotic complications, were observed when bupropion was coadministered with warfarin.
Metabolic and Nutritional
Leg cramps, fever/rhabdomyolysis, and muscle weakness.
Abnormal coordination, depersonalization, emotional lability, hyperkinesia, hypertonia, hypesthesia, vertigo, amnesia, ataxia, derealization, abnormal electroencephalogram (EEG), aggression, akinesia, aphasia, coma, dysarthria, dyskinesia, dystonia, euphoria, extrapyramidal syndrome, hypokinesia, increased libido, neuralgia, neuropathy, paranoid ideation, restlessness, suicide attempt, and unmasking tardive dyskinesia.
Bronchospasm and pneumonia.
Impotence, polyuria, prostate disorder, abnormal ejaculation, cystitis, dyspareunia, dysuria, gynecomastia, menopause, painful erection, salpingitis, urinary incontinence, urinary retention, and vaginitis.
Read the entire FDA prescribing information for Wellbutrin XL (Bupropion Hydrochloride Extended-Release)
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